RU2015144026A - Антитела против cd25 и их применения - Google Patents

Антитела против cd25 и их применения Download PDF

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RU2015144026A
RU2015144026A RU2015144026A RU2015144026A RU2015144026A RU 2015144026 A RU2015144026 A RU 2015144026A RU 2015144026 A RU2015144026 A RU 2015144026A RU 2015144026 A RU2015144026 A RU 2015144026A RU 2015144026 A RU2015144026 A RU 2015144026A
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antibody
sequence
seq
domain
heavy chain
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RU2015144026A
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Йосико АКАМАЦУ
Фиона А. ХАРДИНГ
Пол Р. ХИНТОН
Менгли СЮН
Оливия Дженнифер РАЗО
Шимин Е
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Эббви Байотекнолоджи Лтд.
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    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
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    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
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    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
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    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6849—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a receptor, a cell surface antigen or a cell surface determinant
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    • A—HUMAN NECESSITIES
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    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
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    • C12P21/00—Preparation of peptides or proteins
    • C12P21/005—Glycopeptides, glycoproteins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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    • C07K2317/524—CH2 domain
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    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/567—Framework region [FR]
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    • C07—ORGANIC CHEMISTRY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/71—Decreased effector function due to an Fc-modification
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    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
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    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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Claims (34)

1. Моноклональное антитело против CD25 или связывающий фрагмент моноклонального антитела против CD25, которые:
(a) имеют вариабельную область тяжелой цепи, которая по меньшей мере на 98% идентична SEQ ID NO:1, где указанная тяжелая цепь содержит по меньшей мере замену I48M по сравнению с тяжелой цепью с последовательностью SEQ ID NO:1;
(b) имеют вариабельную область легкой цепи с последовательностью SEQ ID NO:2;
(с) имеют вариантный домен CH2, который идентичен по последовательности по меньшей мере на 90% домену CH2 с последовательностью SEQ ID NO:188, и который, по отношению к домену CH2 с последовательностью SEQ ID NO:188, имеет одну или более замен, выбранных из:
(i) замены V263L;
(ii) замены V266L;
(iii) замены V273, выбранной из V273C, V273E, V273F, V273L, V273M, V273S, V273Y; и
(iv) замены V305, выбранной из V305K и V305W.
2. Антитело или фрагмент по п.1, дополнительно содержащие замену I51L в вариабельной области тяжелой цепи.
3. Антитело или фрагмент по п.1, дополнительно содержащие замену T54S в вариабельной области тяжелой цепи.
4. Антитело или фрагмент по п.3, где антитело или связывающий фрагмент антитела имеют домен Fc, причем указанный домен Fc содержит замены T250Q и M428L.
5. Антитело или фрагмент по п.4, где антитело представляет собой модифицированное антитело изотипа IgG2, имеющее мутацию M3.
6. Моноклональное антитело против CD25 или связывающий фрагмент моноклонального антитела против CD25, которые:
(a) имеют вариабельную область тяжелой цепи с последовательностью SEQ ID NO:1, где указанная тяжелая цепь содержит замены I48V и T54S по сравнению с тяжелой цепью с последовательностью SEQ ID NO:1;
(b) имеют вариабельную область легкой цепи с последовательностью SEQ ID NO:2; и
(с) имеют вариантный домен CH2, который идентичен по последовательности по меньшей мере на 90% домену CH2 с последовательностью SEQ ID NO:188, и который, по отношению к домену CH2 с последовательностью SEQ ID NO:188, имеет одну или более замен, выбранных из:
(i) замены V263L;
(ii) замены V266L;
(iii) замены V273, выбранной из V273C, V273E, V273F, V273L, V273M, V273S, V273Y; и
(iv) замены V305, выбранной из V305K и V305W.
7. Конъюгат «антитело-лекарственное средство», содержащий антитело или фрагмент по любому из пп.1-6.
8. Фармацевтическая композиция, содержащая антитело или фрагмент по любому из пп.1-6.
9. Нуклеиновая кислота, содержащая нуклеотидную последовательность, кодирующую антитело или фрагмент по любому из пп.1-6.
10. Вектор, содержащий нуклеиновую кислоту по п.9.
11. Прокариотическая клетка-хозяин, трансформированная вектором по п.10.
12. Эукариотическая клетка-хозяин, трансформированная вектором по п.10.
13. Эукариотическая клетка-хозяин, сконструированная для экспрессии нуклеотидной последовательности по п.9.
14. Способ получения антитела против CD25 или связывающего фрагмента против CD25, включающий:
(a) культивирование эукариотической клетки-хозяина по п.13; и
(b) выделение антитела против CD25 или связывающего фрагмента против CD25.
15. Способ предотвращения отторжения трансплантата органа, включающий введение нуждающемуся в этом человеку терапевтически эффективного количества фармацевтической композиции по п.8.
16. Способ лечения заболевания, выбранного из астмы, рассеянного склероза, увеита, воспаления глаза или T-клеточного
лейкоза, ассоциированного с вирусом-1 T-клеточного лейкоза человека, включающий введение нуждающемуся в этом человеку терапевтически эффективного количества фармацевтической композиции по п.8.
17. Способ по п.16, где заболевание представляет собой рассеянный склероз.
RU2015144026A 2013-03-15 2014-03-14 Антитела против cd25 и их применения RU2015144026A (ru)

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US201361798235P 2013-03-15 2013-03-15
US61/798,235 2013-03-15
PCT/US2014/029634 WO2014145000A2 (en) 2013-03-15 2014-03-14 Anti-cd25 antibodies and their uses

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US (3) US20150010539A1 (ru)
EP (2) EP3216804A3 (ru)
JP (1) JP2016515524A (ru)
CN (1) CN105377892A (ru)
AU (1) AU2014233478A1 (ru)
BR (1) BR112015023084A2 (ru)
CA (1) CA2904532A1 (ru)
HK (1) HK1220470A1 (ru)
MX (1) MX2015012551A (ru)
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